Clinical Supply When There's No Drug To Ship

By Arkadiusz (Eric) Kubik, Ph.D., Clinical Research and Regulatory Science and Paul Putiatycki

Non-drug arms are becoming more common in clinical trials, not only as stand-alone interventions but also as comparators to pharmacological interventions. Behavioral therapies and non-pharmacologic approaches are being evaluated with the same rigor most commonly reserved for investigational drugs.

A non-pharmacological study, while lacking a dispensable study medication, can still follow a similar approach to a device study. For example, in music therapy, the instrument, or the performer, effectively takes on the role of the investigational product. This requires qualification and training sessions built into the study protocol, as well as proper instrument tuning to maintain the same consistency that a pharmacological product achieves through manufacturing, dosing, and packaging. The goal is to ensure a repeatable process that delivers the same required "dose" each time.

While there's no drug to manufacture or dispense, the same discipline applies to the instrument, the performer, and their environment, and it must extend to everything supplied around them.

What Counts As Supply Now

In a pharmacological trial, supply has a clear boundary: the investigational product, its comparator or placebo, and the materials directly tied to dispensing it. In a non-pharmacological trial, that boundary shifts to things that clinical supply teams don't usually track.

Take a music-based intervention study. Supply now includes the musical instruments themselves, calibrated and maintained to a consistent standard across every site. It includes the audio equipment used to measure and control decibel levels, so the intervention is delivered at the same intensity every time, at every site, for every participant. It includes any recorded or digital content used as part of the intervention, including playlists, audio files, or software, all of which need version control in the same way that a drug lot needs a batch number. It includes participant-facing materials: instructions, session logs, take-home materials, or wearables used to track engagement between visits.

None of this material looks like a drug. All of it behaves like one operationally. Each item needs to be sourced, quality-checked, distributed to sites, tracked, and eventually accounted for, including what happens when equipment is damaged, a device malfunctions, or a participant loses a take-home material partway through the study.

This is where the absence of a formal investigational product framework becomes a liability rather than a simplification. A drug shipment triggers a chain of custody almost automatically; it's built into how pharmacy and supply teams operate. A music player, a set of headphones, or a printed session log doesn't trigger anything unless someone has deliberately built that structure in advance. The risk isn't that these items are inherently harder to manage than a drug. The risk is that nobody has assigned them the same operational seriousness. When ownership is unclear, the consequences can look very similar to a traditional supply problem: inconsistent site execution, missing materials, version control failures, delays, and incomplete reconciliation.

The practical question for clinical supply teams, then, isn't whether these items need to be tracked; it's who decides that they do and how early in study design that decision gets made. The challenge is recognizing early enough that these materials have become part of the study supply chain and need the same planning and discipline applied to traditional IP.

Vendor Sourcing, Barcoding, And Reconciliation

In pharmaceutical drug studies, the study sponsor sources a vendor to prepare and distribute the investigational product. A series of barcodes, serial numbers, lot numbers, and expiry dates are often used. The specific methodology varies by vendor. In my experience managing clinical trials across Canada, the United States, and the European Union, it also varies significantly by region and by the regulatory expectations that govern each.

Study medication is subject to strict expiry dates and temperature controls in all three regions, though the practical handling differs. Expired medication is sometimes permitted to be destroyed on-site, provided the investigational site holds the required documentation, while in other cases it must be returned to the vendor, a process that adds cost and time to the study regardless of jurisdiction.

Across these studies, I have worked with temperature-sensitive tags included with sensitive study medications; once a temperature excursion occurs, the information is automatically sent to the vendor, triggering a resupply of a replacement. I have also done work building a barcoding system tied to the study participant's source documentation, scannable by site staff using a barcode reader or a dedicated cellphone app, to correctly assign study medication to the properly randomized participant and reconcile the medication used, an approach applied consistently across sites in each of these regulatory environments.

A similar approach must be considered for medical devices and equipment used in a non-pharmaceutical clinical trial, such as a music therapy trial. While a music therapy clinical trial would involve no study medication, there is the same requirement, regardless of country or regulatory framework, to maintain a consistent standard across each investigational site hosting the study. This includes ensuring that equipment is adequately tuned to the study protocol requirements and that staff performing the intervention are properly trained. All of this work is possible when the study is designed by someone with an adequate understanding of medical research and the resources required to execute it. Trials that do not involve medications or devices, such as music therapy, should be held to the same accountability standards as pharmacological trials. That means identifying early in the study design what equipment, materials, training, and other resources will be required at each site. Those requirements may include specialized equipment used to deliver, monitor, or assess the intervention, all of which much be sourced, qualified, distributed, and managed consistently across the study.

Site Qualification

Before a study begins, a site qualification process takes place in which the study sponsor assesses whether a site and its team meet the sponsor's expectations. Among other things, the sponsor reviews the existing facility and space and the team to confirm the site meets the sponsor's criteria. A feasibility assessment is also completed to evaluate how experienced the staff, including the investigator and coordinators, are with the specific type of clinical trial. The sponsor will also review whether the site has adequate facilities to conduct the study and whether it has any equipment that may need to be provided. For a clinical trial involving music therapy, sites are expected to exceed these standard expectations, to ensure that data collected and outcomes measured meet the same level of rigor as a pharmacological trial.

Training And Qualifying Study Staff

Regardless of whether a study involves a physical pharmaceutical drug, a medical device, or an intangible audio-based therapy such as music therapy, the same medical research principles apply to eliminating deviations from the study protocol and maximizing efficiency. Study staff should be well qualified, with prior clinical trial experience and a formal background in biotech, medicine, or medical research. Not all medical professionals have a medical research background; this area falls outside the standard scope of practice for physicians, nurses, or dentists and requires additional medical research knowledge beyond standard GCP training. This additional training is itself a mitigating factor: By equipping the study team with the specific skills needed to perform the intervention correctly, it directly reduces the likelihood of protocol deviations occurring in the first place.

A project manager without a formal medical or medical research background may still be effective at managing the study and helping the sponsor and site meet enrollment targets. However, this operational effectiveness cannot substitute for the formal related qualifications required to design and oversee the scientific integrity of the study itself.

Cost And Funding

The most challenging aspect of a successful music therapy trial is ensuring that study staff can replicate the intervention exactly the same way each time, per the study protocol. The costs associated with running such a study would be lower than those of a conventional pharmaceutical study, and funding can be obtained from a potential sponsor, as well as from Horizon Europe, the European Union's largest-ever flagship framework for research and innovation, operating with a total budget of €95.5 billion through 2027. It is designed to foster international collaboration, address major global challenges, and accelerate technological and medical advances. I have previously obtained EU grant funding for the purchase of state-of-the-art medical equipment.

Taken together, these considerations show that the absence of an investigational product does not eliminate the need for clinical supply; it changes what the supply chain has to recognize, control, and deliver.

About The Authors:

Dr. Arkadiusz (Eric) Kubik is a clinical research and regulatory science professional with a Ph.D. in medical sciences and extensive experience supporting FDA- and Health Canada-regulated clinical trials. He has contributed to more than 50 Phase I–IV studies involving pharmaceuticals and medical devices, with expertise in clinical operations, regulatory compliance, patient safety, and evidence generation. His work integrates biomedical research, toxicology, biomaterials science, and regulatory strategy to advance safe and effective healthcare innovations. Dr. Kubik has collaborated with academic institutions, pharmaceutical sponsors, and leading research organizations. He has also shared his expertise with the public through media engagement, including a radio appearance in Chicago, Illinois, discussing healthcare and scientific topics.

Paul Putiatycki is a prospective medical student with experiences in clinical, wet-lab, and dry-lab research. He currently is a research assistant at the University of Chicago School of Medicine Bissonnette lab focusing on Gastrointestinal cancer research. Paul has also competed in international research competitions most predominantly placing 3rd in an Alzheimer’s white paper competition.